FDA Approves Mavyret for Treatment of Acute HCV Infection
The therapy is the first and only oral direct acting antiviral approved by the FDA for HCV infection.
The FDA approved a label expansion for glecaprevir/pibrentasvir (Mavyret) to treat acute hepatitis C virus (HCV) infection in patients 3 years of age and older with compensated cirrhosis or without cirrhosis, AbbVie announced in a release.1 The therapy, which is now approved for both acute and chronic HCV, is the first and only oral direct acting antiviral approved by the FDA for this condition.
FDA Approves Mavyret for Treatment of Acute Hepatitis C Virus / Tada Images - stock.adobe.com
The expanded label approval was based on data from a phase 3 study (NCT04903626), in which glecaprevir/pibrentasvir showed a high efficacy in treating HCV. The therapy was also seen to be generally well tolerated, with most reported adverse events being either mild or moderate in severity.
"The physical, emotional, and economic burden of a curable condition like hepatitis C is far too great in the United States and around the world," John Ward, MD, director of the Coalition for Global Hepatitis Elimination, said in a release.1 "If treated early with safe and effective therapies, providers can cure virtually all patients with hepatitis C before it escalates to chronic disease and eventually cirrhosis or liver cancer. The public health community now has a good opportunity to cure nearly all persons to support eliminating the toll of this deadly virus. No one should die of hepatitis C."
The study was a multicenter, single-arm prospective phase 3 clinical trial that evaluated the efficacy and safety of glecaprevir/pibrentasvir in adult and pediatric patients with an acute HCV infection. The primary study endpoint was the percentage of patients with sustained virological response 12 weeks (SVR12) after treatment. Secondary endpoints included the percentage of patients with on-treatment virologic failure and post-treatment relapse.
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The study cohort included 283 patients 12 years of age or older with an acute HCV Infection who were treatment-naïve. Patients received an oral tablet of glecaprevir/pibrentasvir once per day for 8 weeks with 12 weeks of follow up after treatment. Patients were excluded from the study if they received prior treatment for HCV, including interferon, or had a history of liver decompensation.
The study found that 96.2% of patients who received the therapy met SVR12 in the intention to treat group and 100% met SVR12 in the modified intention to treat-virologic failure group. Additionally, no patients in the intention to treat group relapsed after treatment. The most common adverse events were fatigue, asthenia, headache, and diarrhea.
"Mavyret has treated more than 1 million patients with HCV, but we recognize that a significant need remains for patients with acute infection," Roopal Thakkar, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in a release.1 "The label expansion for Mavyret, coupled with the implementation of test and treat models of care, serve as tools to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal."
Glecaprevir/pibrentasvir was initially approved by the FDA in 2017 for adults with chronic HCV infection.2 The therapy was previously granted breakthrough therapy designation by the FDA in 2016 for the treatment of patients with HCV who were not cured with prior DAA therapy based on data from the phase 2 MAGELLAN-1 study.3
READ MORE: Infectious Disease Resource Center
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